Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05975671
Status
Recruiting
Apply to this trial

Conditions

  • Antimicrobial - Induced Nephropathy
  • Sepsis
  • Sepsis Bacteremia
  • Sepsis Mrsa
  • Sepsis, Severe
  • Septic Shock
  • Septic Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multifaceted de-implementation strategy to reduce vancomycin overuse — BEHAVIORAL
    * Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site. * The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews. * The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.

Study Details

The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include: * Implementation of a clinical guideline indicating when vancomycin should and should not be used * Unit-level feedback on overall vancomycin use within and across centers * Clinician education.

Key Dates

Start date
Aug 21, 2023
Status verified
Sep 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
52,500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: PICU Clinicians and Sepsis stakeholders
    Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention: * All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention. * Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders. * Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.
  • No Intervention: PICU Patients with suspected sepsis
    Research procedures involving patients will be limited to medical record review. This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes. Approximately 50,000 patients will participate in the study. Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files. These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode). The study Identification (ID) number will be used to identify each unique patient. Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies.

Primary Outcome Measure

Change in vancomycin use [ Time Frame: Baseline to 5 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322
Preeti Jaggi, MD
[email protected]
404-727-4807
Johns Hopkins Children's CenterBaltimoreMaryland21287
Pranita Tamma, MD, MPH
[email protected]
St. Louis Children's HospitalSt LouisMissouri63110
Evan Facer, DO
[email protected]
314-454-6050
Luke Starnes, PhD
[email protected]
314-286-2092
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19146
Kathleen Chiotos, MD, MSCE
[email protected]
215-590-5505
Kathleen Chiotos (PRINCIPAL_INVESTIGATOR)
Rebecca Same (SUB_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Children's Healthcare of Atlanta· Atlanta, GAJohns Hopkins Children's Center· Baltimore, MDSt. Louis Children's Hospital· St Louis, MOChildren's Hospital of Philadelphia· Philadelphia, PA

Related Studies